510(k) · Cleared
ClearedDigitrace Sleep Computer, Sleeppac, Home Sleep System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New England Medical Monitoring Co. · OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Cleared on May 4, 1995 after a 216-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 62 later devices descend from it.
- Decided
- May 4, 1995
- Review
- 216 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 0
62 later devices descend from it, 1 citing it directly.
- This deviceK944833 Digitrace Sleep Computer, Sleeppac, Home Sleep SystemNew England Medical Monitoring Co. · 1995
- Descendant · cites it directly · 61 of its ownK971813 EMBLAFerguson Medical · 1998
- Descendant · 2 generations on · 25 of its ownK080427 Watch-Pat Model 100S-2Itamar Medical · 2008
- Descendant · 3 generations on · 24 of its ownK081982 Watch-Pat 200S-2 (WP200S-2)Itamar Medical · 2008
- Descendant · 2 generations on · 23 of its ownK102567 Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd. · 2011
- Descendant · 2 generations on · 23 of its ownK070375 Earlysense ES-16 SystemEarlysense, Ltd. · 2007
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K971813EMBLAFerguson Medical · 1998 · cites it directly61descendants
- K080427Watch-Pat Model 100S-2Itamar Medical · 2008 · 2 generations on25descendants
- K081982Watch-Pat 200S-2 (WP200S-2)Itamar Medical · 2008 · 3 generations on24descendants
- K102567Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd. · 2011 · 2 generations on23descendants
- K070375Earlysense ES-16 SystemEarlysense, Ltd. · 2007 · 2 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944833 | Digitrace Sleep Computer, Sleeppac, Home Sleep System | New England Medical Monitoring Co. | 1995 | — |
| +1 | K971813 | EMBLA | Ferguson Medical | 1998 | — |
| +2 | K080427 | Watch-Pat Model 100S-2 | Itamar Medical | 2008 | — |
| +3 | K081982 | Watch-Pat 200S-2 (WP200S-2) | Itamar Medical | 2008 | — |
| +2 | K102567 | Watch-Pat 200S-3 (WP200S-3) | Itamar Medical, Ltd. | 2011 | — |
| +2 | K070375 | Earlysense ES-16 System | Earlysense, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 9 | 0 |
| 2026 | 8 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OMB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OMB device
- #1 K240993 encevis (2.1)score 15.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (62)
See all 621 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971813 | EMBLA | 1998 | 61 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K971813 (Ferguson Medical, 1998) has gone furthest, with 61 descendants of its own.
How does its category compare?
All OMB devicesOMB Automatic Event Detection Software For Full-Montage Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OMB
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMB
143in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMB
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMB
6in 2025
MAUDE reports naming product code OMB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 3 | 233 | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 108 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 1 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 5 | 201 | 0 | 21 |
| 2025 | 5 | 143 | 0 | 6 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K944833 · printed Nov 4, 2026
Cite this page
510(k) Report. “K944833: Digitrace Sleep Computer, Sleeppac, Home Sleep System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944833
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026